PROLOR Biotech, Inc. (PBTH)

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7:32AM PROLOR Biotech reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor VIIa in hemophilic mice (PBTH) 4.20 : Co reported positive results from a comparative study of its biobetter longer-acting version of the hemophilia drug Factor VIIa in hemophilic mice. The study was designed to measure the potential increase in half-life and clotting activity of PROLOR's long-acting CTP-modified Factor VIIa when compared with commercially available recombinant Factor VIIa. In the preclinical study, Factor VIIa-CTP, when compared with commercially available Factor VIIa, demonstrated a significantly longer half-life and duration of clotting activity in the hemophilic mice model.

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PROLOR Biotech to Host Investor Conference Call

http://finance.yahoo.com/news/PROLOR-Biotech-to-Host-prnews-2817263803.html?x=0&.v=1

NES-ZIONA, Israel, Aug. 24, 2011 /PRNewswire/ --

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will host an investor conference call and webcast on September 7, 2011 to review recently announced corporate developments, including the positive results from the company's Phase II trial of hGH-CTP, its long-acting version of human growth hormone.

A question-and-answer session will follow management's discussion. All interested parties are encouraged to listen to the live conference call or the live or archived webcast.

The conference call and webcast will begin at 8:30 am EDT. To listen to a live broadcast of the call over the Internet or to review the archived webcast, please visit the Investors section of PROLOR's website at www.prolor-biotech.com.

Those investors who prefer to participate by telephone, or who want to ask questions during the conference call, should dial the following number approximately 10 minutes prior to the scheduled start time and request to join the PROLOR Biotech call at: 1-800-860-2442 begin_of_the_skype_highlighting 1-800-860-2442 end_of_the_skype_highlighting (within the US) or 1-412-858-4600 begin_of_the_skype_highlighting 1-412-858-4600 end_of_the_skype_highlighting (for international calls).

A copy of the company's updated corporate presentation, which includes a top-line analysis of data from the Phase II trial of hGH-CTP, will be available at the start of the call on September 7, 2011 under "Presentations" in the Investors section of PROLOR's website at www.prolor-biotech.com.

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is completing Phase II clinical development, as well as Factor VII, Factor IX, interferon beta, erythropoietin, an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis, which are all in preclinical development. For more information, visit www.prolor-biotech.com.

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7:31AM PROLOR Biotech says long-acting human growth hormone awarded $1.7 mln Israeli government grant (PBTH) 4.99 : Co announces that the Israeli Office of the Chief Scientist has approved a 2011 grant to PROLOR's Israeli-based R&D subsidiary for the company's development program for hGH-CTP, its long-acting version of human growth hormone. The OCS approved a grant of $1.7 million to support PROLOR's hGH-CTP program for 2011.

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>>> PROLOR Biotech Announces Positive Top-Line Results From Phase II Trial of its Long-Acting Human Growth Hormone That Achieved All Key Study Goals


--Trial of hGH-CTP in Growth Hormone Deficient Adults Achieved Key Efficacy and Safety Endpoints--

--Positive Results Set Stage for Initiating Phase III Trial Expected to Begin in 2012--



PROLOR Biotech, Inc
August 4, 2011



http://finance.yahoo.com/news/PROLOR-Biotech-Announces-prnews-2852349068.html?x=0&.v=1




NES-ZIONA, Israel, Aug. 4, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported positive results from a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The data show that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone (hGH).

"The findings from the Phase II trial are very promising for adults in need of growth hormone therapy and their physicians," said Dr. Avri Havron, Chief Executive Officer of PROLOR. "The results show that hGH-CTP can potentially provide an exceptional therapy for adults with growth hormone deficiency when given once weekly, while demonstrating an excellent safety and tolerability profile across all doses and for all patients in the trial. The Phase II trial results have enabled us to identify the most suitable dose range of hGH-CTP for our planned Phase III trial, and we look forward to its anticipated initiation in 2012."

"Based on these positive results, PROLOR is offering patients who participated in the Phase II trial the opportunity to continue treatment with single weekly injections of hGH-CTP for an additional four months," noted Shai Novik, President of PROLOR. "Based on feedback from patients and their physicians, we expect that the majority of patients who completed the Phase II study will elect to participate in the four-month extension period, which we view as a powerful endorsement of hGH-CTP in view of the fact that those patients who elect to participate will have to undergo continued clinical monitoring requirements such as routine blood collections. We expect that information from the voluntary extension period will provide additional data enabling us to further verify the anticipated doses and titration schedule of hGH-CTP for the planned Phase III trial."

The objectives of the randomized open-label, multicenter Phase II trial were to measure the safety and tolerability of hGH-CTP in growth hormone deficient adults and to assess dose ranging and dose response in order to identify the dose range that will be targeted in the planned Phase III trial.

Design of the Phase II Trial

The three main cohorts in the trial received a single weekly dose of hGH-CTP for a period of four weeks, containing 30%, 45% or 100% of the equivalent cumulative commercial hGH dose these patients would usually inject each day over the course of seven days (referred to as the "30%," "45%" and "100%" cohorts, respectively.) The top-line data reflect results from 39 patients, with 13 patients in each cohort comprised of 11 males and two females.

In addition to the three main cohorts, PROLOR researchers are also enrolling growth hormone deficient adults in an experimental fourth cohort, which is being conducted outside of the formal Phase II trial. The patients in the experimental fourth cohort are receiving a single injection of hGH-CTP once every two weeks that contains 50% of the cumulative commercial dose of hGH that they would usually inject each day during a two-week period. Enrollment in this experimental cohort is ongoing.

Efficacy for the three main cohorts receiving a single weekly injection of hGH-CTP is defined by measuring daily insulin-like growth factor 1 (IGF-1) levels within the desired therapeutic range over a period of seven days during the last week of treatment in the study. The desired therapeutic range is defined as an IGF-1 level that is between +2 standard deviations through -2 standard deviations from the average IGF-1 levels expected in a normal population stratified by age group and gender. In addition, the trial measured IGF-1 levels within a narrower range of +/- 1.5 standard deviations from the average normal population IGF-1 levels, for the purpose of learning more about the variance of patients within the normal range.

Phase II Trial Top-Line Data Analysis

As shown in the table below, the study data show that patients in all three cohorts (the "30%," "45%" and "100%" cohorts) achieved average IGF-1 levels that were within the normal range on 100% of the days when they were assessed. In addition, the data show that patients in each of the cohorts achieved average IGF-1 levels within the narrow definition of the normal range on many or most of the days when they were assessed, indicating a favorable variance profile within the normal range.

hGH-CTP demonstrated excellent safety and tolerability in all patients across all trial cohorts, with no apparent issues. In addition, there were no indications that hGH-CTP can induce excessive levels of IGF-1 in patients above the normal range when used in high doses.

Based on the Phase II study results, PROLOR researchers estimate that 2mg per week of hGH-CTP, containing 50% of the cumulative weekly hGH dose that an adult patient would usually be prescribed as the initial treatment dose, has a high likelihood of being defined as the starting dose for males and females in the adult Phase III trial.

ABOUT PROLOR

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, as well as Factor VII, Factor IX, interferon beta, erythropoietin, an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis, which are all in preclinical development. For more information, visit www.prolor-biotech.com.

<<<

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6:04AM PROLOR Biotech announces positive top-line results from Phase II trial of its long-acting human growth hormone that achieved all key study goals (PBTH) 5.42 : Co reported positive results from a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone (hGH-CTP) in growth hormone deficient adults. The data show that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. In addition to the three main cohorts, PROLOR researchers are also enrolling growth hormone deficient adults in an experimental fourth cohort, which is being conducted outside of the formal Phase II trial. Positive results set stage for initiating Phase III trial expected to begin in 2012.

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>>> PROLOR: The Added Value Of Reversible PEGYlation

Wednesday, 30 March 2011 15:03



http://www.prohostbiotech.com/item/688-ltspan/688-ltspan.html



When Professor Irving Boime and his team at Washington University in St. Louis observed that human chorionic gonadotropin (hCG) has a longer half life than other natural hormones, researchers’ curiosity led them to discover that a carboxyl terminal peptide (CTP) linked to the hormone molecule increases its half life. Experimenting with CTP on other proteins left no doubt in the minds of the researchers that linking Nature’s CTP to protein therapeutics could be safe and effective in extending their half-life. When it comes to reproduction, Mother Nature does not err and does not cause harm. It selected CTP to link to the hormone, which without it, pregnancy would have never been possible. Read also The Value of CTP Technology

Washington University in St. Louis granted Prolor Biotech (PBTH) an exclusive license to use the CTP technology with the exception of four proteins; follicle stimulating hormone (FSH), human chorionic gonadotropin (hCG), luteinizing hormone (LH) and thyroid stimulating hormone (TSH), which ended up in Merck’s lap. Having secured the rights to CTP, Prolor’s priority has been to develop long acting versions of approved protein therapeutics that have the least troubling clinical trial requirements, which would be money draining and time-consuming. Modifying approved therapeutic proteins requires less time for preclinical and clinical development than molecules that have yet to be proven safe and effective.

As Prolor’s products were advancing in clinical trials, the firm made a surprising announcement; declaring it has secured the right to a new technology dubbed Reversible PEGylation. While granting the right to this state-of-the-art technology to Prolor was the envy of many drug delivery firms and other pharmaceutical companies, it looked as if many investors missed noticing the breakthrough nature of this elegant technology that, when added to the CTP technology, would tremendously increase of the number of modified products in Prolor’s pipeline.

What’s is the story? Why is Prolor interested in extending the half-life of proteins, peptides and other small molecule therapeutics? Why did this firm add another technology to its safe and effective CTP technology?

Short half-life and poor bioavailability of parenteral therapeutic proteins and peptides renders them unstable, poorly effective and plagued with adverse effects. The tremendous increase in the number of protein and peptide therapeutics following the establishment of the biotech industry necessitates the discovery of modifying technologies that would prolong the half-life of these molecules without compromising their mode of action and efficacy. Unfortunately, despite the introduction of many technologies, the badly needed safe and effective approaches towards prolonging the half-life of these molecules remain badly needed. Of the many therapeutic proteins and peptides that have been approved and generating billions of dollars in revenues, a few only were modified, making them safer, less expensive and more convenient for the patients. Here comes the role of CTP and Reversible PEGylation technologies, which ended up in the hands of prominent scientists at Prolor Biotech.

By imitating nature and attaching CTP to existing therapeutic proteins, Prolor was able to stabilize and extend the half-life of therapeutic proteins without impacting their desired biological activity or therapeutic efficacy. The new approach has been validated through various clinical trials and, more importantly, by the approval in Europe of Elonva®, an extended release follicle stimulating hormone (CTP-FSH), one of the four products licensed to Merck by Washington University St. Louis. Elonva is used together with a gonadotrophin-releasing hormone (GnRH) antagonist in women undergoing fertility treatment. One subcutaneous injection of Elonva has replaced many injections required daily for other recombinant follicle stimulating hormone (rFSH) preparations to do the job.

As Prolor’s CTP product pipeline is growing, trials are further confirming the safety and efficacy of the approach. The firm’s lead product (CTP-rhGH) is a modified version of the recombinant human growth hormone, which is approved for children and adults. In children, it is prescribed for long-term treatment of growth failure due to inadequate endogenous growth hormone. For adults, hGH is approved for severely hGH-deficient adult patients. CTP-rhGH is now in phase II trial after demonstrating in Phase I trial that two monthly injections can replace daily injections of the conventional hormone. Results have also demonstrated that the treatment has increased IGF-1 level, an evidence-based proof of CTP-hGH activity. The IGF-1 levels are agreed upon marker of hGH activity. This is good news.

Prolongation of rhGH action has long been recognized as a necessity for all the reasons mentioned above, but more importantly for the sake of children, who are enduring a shot everyday for a long, long time. It needed CTP to be attached to the hormone to make it easy for short-stature children to comply with the treatment, as it did thousands of years ago to chorionic gonadotropin, which enabled children to exist in the first place.

In early February, an Independent Data Safety Monitoring Board decided that the drug is safe and recommended continuing the trials as they have been planned. This is good news. It indicates that the firm’s trial plans are good enough to provide all the necessary data that a Phase II trial must provide. The results are expected in the third quarter of this year. This is another good news. We are optimistic. The market is large and is still growing, especially for adults. The market for hGH has been stretched several times in the past; the largest was when it was approved in the U.S. for HIV-related wasting. High doses of hGH have been found to increase the weight and lean body mass in people with AIDS. The loss of lean body mass is the form of wasting is most closely related to an increased risk of death.

Prolor’s current pipeline includes additional CTP-formulated products, which include interferon beta candidate (IFN-B-CTP); Factor VIIab (FVII-CTP); an erythropoietin candidate (EPO-CTP); a product for type 2 diabetes (GLP-1-CTP) and the obesity candidate OBES-CTP (MOD-1002).

On January 18, 2011, Prolor announced it entered into a definitive license agreement with Yeda Research and Development Company Ltd. Upon the agreement, Prolor would use the state-of-the-art novel Reversible PEGylation technology to develop sustained release small molecule peptide and protein therapeutics. Following the announcement, some investors expressed an uneasy feeling towards the news, while others that we mentioned in the beginning of this article have been totally indifferent to it. Some shareholders did not like the fact that Prolor is using the Reversible PEGylation technology in developing an obesity drug. A series of recent FDA rejections of obesity drugs have misled investors into falsely believing that, for one reason or another, the FDA has decided to make it extremely difficult approving obesity drugs, regardless of their safety and efficacy. Some investors thought that Reversible PEGylation is the conventional PEGylation approach, which is described as inefficient for the modification of proteins and peptides.

To clarify the confusion, we thought investors should know more about Yeda, about Reversible PEGylation and about the obesity drug. To begin with, the technology belongs to Weizmann Institute of Science (WIS) – a world leader in research and graduate education. The Institute’s state-of-the-art technologies and research have led to many discoveries and inventions that have huge commercial potential. In 1959, WIS established Yeda as a research and development company, which, in due course, has become one of the World's most successful technology organizations for the transfer of breakthrough discoveries. So Yeda is not a small, unknown company, but a viable arm of WIS. The mere fact that Yeda decided to grant Prolor the right to the Reversible PEGylation is that the Weisman Institutes of Science viewed Prolor’s scientists as highly qualified to effectively use the technology in developing and commercializing breakthrough therapeutics.

Reversible PEGylation is a breakthrough technology developed to boost the half-life and biological activities of small molecule candidates as well as peptides and proteins without changing the mode of action of the therapeutic molecules and improving their pharmacokinetics. The worst problem in PEGylation is the fact that the polyethylene glycol polymers block the active sites of the therapeutic molecules. In Reversible PEGylation, PEG polymers are attached to the drug with chain-like structures held in place by chemical bonds that gradually dissolve in the bloodstream, enabling the PEG molecules to detach in a measurable way from the drug. As they detach, the native molecules are released into the blood in a slow, constant, and predictable manner.

Many scientists, including Prolor’s have validated this genius approach. As a matter of fact, Prolor was able to negotiate its exclusive license for reversible PEGylation after its success in developing a preclinical-stage long-acting oxyntomodulin anti-obesity candidate using Reversible PEGylation platform under an option-to-license agreement. Having accomplished its job successfully, Prolor was awarded the right to use Reversible PEGylation, not only for the drug in hand, but for all therapeutic indications except hemophilia and insulin.

With regard to obesity, Oxyntomodulin, which Prolor is actively developing into a sustained release formulation, is totally different from the drugs that were denied FDA approval. The rejected drugs had little or no effect on weight loss, or failed the reward versus risk test, especially for a non-terminal stage sickness. Oxyntomodulin is a natural peptide hormone that is released by the digestive system following food ingestion. It acts as a natural satiety signal to reduce food intake and increase energy expenditure. Prolor has chosen a natural, safe body product to fight overeating. Previous human studies conducted by other groups have demonstrated the potential of oxyntomodulin in reducing appetite and food intake, leading to significant weight loss with minimal side effects. As oxyntomodulin has a short half-life, which requires frequent dosing that is arduous for the drug takers, it needed modification that prolongs its half-life. Reverse PEGylation was the option of choice for extending oxyntomodulin’s half life, making the drug user friendly, i.e., easy for the patients to take, so they would comply with the prescribing directions.

Adding Reverse PEGylation to CTP technology enables Prolor to realize its vision of filling its pipeline with modified approved therapeutic proteins and peptides that are already generating billions of dollars in revenues and other molecules, small, or large, that promise blockbuster drugs. <<<

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still looking at this bullish falling wedge or pennant.

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PROLOR Attracts Two Very Bullish Analysts

PROLOR Biotech Inc., a biotechnology company utilizing its technology to develop versions of therapeutic proteins, was initiated by both Summer Street and Morgan Joseph this week. With price targets of $8.00 and $16.00 per share respectively, both analysts appear to have a very bullish stance on the future of this unique biotech stock.

The Israeli biotech company has turned a few heads with its proprietary CTP enhanced recombinant protein technology. By utilizing these technologies, the company hopes to move through clinical trials more quickly and less expensively by focusing on the same endpoints and protocols as existing therapies. Meanwhile, Phase II trials showed that its hGH-CTP was both well-tolerated and demonstrated a half-life that was 10x longer than commercial hGH.

While the stock’s performance has been somewhat lackluster in 2011, many biotech investors are betting that the full release of its Phase II results and continued clinical progress will provide near-term and long-term catalysts as well as drive value.

http://seekingalpha.com/article/279194-profit-from-these-3-analysts-stock-picks-for-under-10?source=yahoo

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fly on the wall: Prolor Biotech initiated with a Buy at Morgan Joseph

On Tuesday July 12, 2011, 8:25 am
Target $16.

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I hadn't seen some of the recent pbth news... I missed that obesity peptide thing or I immediately forgot about it. I see factor IX and these "as well as agents for atherosclerosis and rheumatoid arthritis" as new events... they aren't on prolor website yet and I hadn't seen them before.

at the bottom is an update of a similar chart.

the other link down there is to the anti obesity drug preclinical data.

PROLOR Biotech Receives New U.S. Patent Allowance Covering Broad Applications of Its CTP Platform for Long Acting Therapeutic Proteins

NES-ZIONA, Israel, July 11, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for a patent application covering the company's CTP platform, which has the potential to extend the duration of activity of virtually all therapeutic proteins. The allowed claims cover CTP-modified compositions of a wide array of classes of therapeutic proteins, including hormones, high affinity protein ligands, proteins that induce or regulate an immune response, proteins that are involved with autocrine and paracrine activities, and mimetics of these therapeutic proteins, as well as other types of proteins.

"Allowance of this new patent is of great importance for PROLOR's intellectual property portfolio, since it covers a very wide array of therapeutic proteins and extends the patent protection around our CTP platform for many years," said Shai Novik, president of PROLOR. "In addition to this key new patent, we have several other CTP-related patent applications that are currently pending. We are confident that our growing CTP patent portfolio will provide significant protection for both our compounds in development and our platform technology, and we believe it will serve as an important value driver for PROLOR in the future."

This new U.S. patent is expected to issue in the next few months.

About PROLOR's CTP Technology

PROLOR's CTP technology is based on the naturally occurring human Carboxyl Terminal Peptide (CTP). When attached to a therapeutic protein, CTP significantly extends the length of time the protein remains active in the body. Clinical and preclinical studies show that the CTP technology appears to be safe and effective in extending the duration of all proteins tested to date. CTP's safety and efficacy have also been validated by the 2010 EU marketing approval of Merck's long-acting fertility drug Elonva® (FSH-CTP). A single Elonva injection replaces a week-long regimen of seven daily FSH injections. PROLOR recently announced interim efficacy results from a Phase II trial of its CTP-modified human growth hormone (hGH-CTP) in growth hormone deficient adults, showing that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. CTP was identified by researchers at Washington University in St. Louis and is exclusively licensed to PROLOR for all proteins and peptides, except for four endocrine proteins that are licensed to Merck. CTP is manufactured using standard industrial biotech processes.

ABOUT PROLOR

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology and its Reversible Pegylation technology, primarily to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and the Reversible Pegylation technology is well-suited for use with peptides and small molecule therapeutics. PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, and Factor IX, Factor VII, interferon beta, anti-obesity peptide OXY-RPEG and erythropoietin, which are in preclinical development, as well as agents for atherosclerosis and rheumatoid arthritis. For more information, visit www.prolor-biotech.com.


http://www.prolor-biotech.com/_Uploads/dbsAttachedFiles/NewsPROLORAnnouncesPositivePreclinicalResultsInObesityStudy.PDF

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http://www.nasdaq.com/asp/holdings.asp?symbol=PBTH&selected=PBTH&FormType=Institutional

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PROLOR Biotech Receives New U.S. Patent Allowance Covering Broad Applications of Its CTP Platform for Long Acting Therapeutic Proteins

Press Release Source: PROLOR Biotech, Inc. On Monday July 11, 2011, 7:30 am EDT

NES-ZIONA, Israel, July 11, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), today announced that it has received a notice of allowance from the U.S. Patent and Trademark Office (PTO) for a patent application covering the company's CTP platform, which has the potential to extend the duration of activity of virtually all therapeutic proteins. The allowed claims cover CTP-modified compositions of a wide array of classes of therapeutic proteins, including hormones, high affinity protein ligands, proteins that induce or regulate an immune response, proteins that are involved with autocrine and paracrine activities, and mimetics of these therapeutic proteins, as well as other types of proteins.

"Allowance of this new patent is of great importance for PROLOR's intellectual property portfolio, since it covers a very wide array of therapeutic proteins and extends the patent protection around our CTP platform for many years," said Shai Novik, president of PROLOR. "In addition to this key new patent, we have several other CTP-related patent applications that are currently pending. We are confident that our growing CTP patent portfolio will provide significant protection for both our compounds in development and our platform technology, and we believe it will serve as an important value driver for PROLOR in the future."

This new U.S. patent is expected to issue in the next few months.

About PROLOR's CTP Technology

PROLOR's CTP technology is based on the naturally occurring human Carboxyl Terminal Peptide (CTP). When attached to a therapeutic protein, CTP significantly extends the length of time the protein remains active in the body. Clinical and preclinical studies show that the CTP technology appears to be safe and effective in extending the duration of all proteins tested to date. CTP's safety and efficacy have also been validated by the 2010 EU marketing approval of Merck's long-acting fertility drug Elonva® (FSH-CTP). A single Elonva injection replaces a week-long regimen of seven daily FSH injections. PROLOR recently announced interim efficacy results from a Phase II trial of its CTP-modified human growth hormone (hGH-CTP) in growth hormone deficient adults, showing that a single weekly injection of hGH-CTP has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. CTP was identified by researchers at Washington University in St. Louis and is exclusively licensed to PROLOR for all proteins and peptides, except for four endocrine proteins that are licensed to Merck. CTP is manufactured using standard industrial biotech processes.

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http://www.secform4.com/insider-trading/1268659.htm

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PBTH ideas

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7:03AM PROLOR Biotech reported positive results from a comparative animal study of its long-acting anti-obesity drug candidate oxyntomodulin (PBTH) 5.01 : Co reported positive results from a comparative animal study of its long-acting anti-obesity drug candidate oxyntomodulin (OXY-RPEG). The study measured the potential therapeutic effect of OXY-RPEG injected once or twice weekly as measured by weight loss and reduction in food intake compared with oxyntomodulin injected twice daily. It was conducted using a state-of-the-art animal model specifically designed to test anti-obesity drugs. In the study, OXY-RPEG injected either once or twice over a period of seven days demonstrated significantly higher weight loss, reduction of food intake and duration of weight loss activity compared with oxyntomodulin injected twice daily.

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pbth looks like double bottomed. I hadn't seen this from the other day.
maybe this is a triple bottom:



NES-ZIONA, Israel, May 10, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the 12th Annual Oppenheimer Israeli Conference, to be held at the David Intercontinental Hotel in Tel Aviv, Israel. The presentation is scheduled for May 15, 2011 at 3:05 pm local time.



PROLOR Biotech to Present at 12th Annual Oppenheimer Israeli Conference

tweet0EmailPrint..Companies:PROLOR Biotech, Inc..Related Quotes
Symbol Price Change
PBTH 5.2299 +0.2399


{"s" : "pbth","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""} Press Release Source: PROLOR Biotech, Inc. On Tuesday May 10, 2011, 7:30 am EDT
NES-ZIONA, Israel, May 10, 2011 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a clinical stage company developing next generation biobetter therapeutic proteins, today announced that company management will give a corporate presentation at the 12th Annual Oppenheimer Israeli Conference, to be held at the David Intercontinental Hotel in Tel Aviv, Israel. The presentation is scheduled for May 15, 2011 at 3:05 pm local time.

A copy of the company's updated corporate presentation, which includes an interim analysis of data from the company's Phase II trial of hGH-CTP, a long-acting version of human growth hormone, will be available starting on May 12, 2011 at the Investors section of PROLOR's website at www.prolor-biotech.com/?CategoryID=216

Shai Novik, President of PROLOR noted, "This is an exciting time for PROLOR. The recent positive results from the interim analysis of our Phase ll trial showed that one injection of hGH-CTP has the potential to replace seven daily doses of commercial human growth hormone. This sets the stage for us to complete the Phase II trial and advance preparations for our hGH-CTP Phase III registration trial planned for next year. We welcome the opportunity to discuss our pipeline and recent progress with Israeli and US investors at this important conference."

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, and Factor IX, Factor VII, interferon beta and erythropoietin, which are in preclinical development, as well as an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis. For more information, visit www.prolor-biotech.com.

PROLOR CONTACT:
Shai Novik, President
PROLOR Biotech, Inc.
Tel: [phone]
Email: [e-mail]

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7:33AM PROLOR Biotech reports positive interim results from Phase II Trial of its long-acting human growth hormone; Phase II Trial expected to be completed as planned by mid-year (PBTH) 5.98 : Co announces positive interim efficacy results from a Phase II clinical trial of its long-acting CTP-modified version of human growth hormone in growth hormone deficient adults. The interim efficacy data show that a single weekly injection of hGH-CTP, even when administered at relatively low doses, has the potential to replace seven consecutive daily injections of currently marketed human growth hormone. "We expect to complete this Phase II trial around mid-year. Based on these promising interim data, we are increasingly confident that the Phase II trial will provide sufficient information to enable our researchers to establish the most suitable doses of hGH-CTP for our planned Phase III registration trial in adults with growth hormone deficiency."

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Nice recovery off test of support
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59499907

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Nice recovery off test of support
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=59499907

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still here 0815ax?

Saw this just today:

PROLOR BIOTECH SIGNS EXCLUSIVE LICENSE AGREEMENT WITH YEDA FOR LONG-ACTING PEPTIDES AND SMALL MOLECULES INCLUDING OXYNTOMODULIN FOR ANTI-OBESITY APPLICATIONS
Nes-Ziona, Israel – January 18, 2011 – PROLOR Biotech, Inc., (NYSE Amex: PBTH), today announced that it has entered into a definitive license agreement with Yeda Research and Development Company Ltd. for novel technology utilized in the development of long-acting therapeutic peptides and small molecules, termed Reversible PEGylation. The Reversible PEGylation technology has been shown in animal models to significantly enhance the half-life and improve the biological activity of a variety of peptides and small molecules, including the diabetes-related compound exendin-4, the appetite suppressant peptide PYY, the blood pressure controlling hormone ANP and the intravenous antibiotic drug gentamicin.
PROLOR has been developing, under a limited option-to-license agreement from Yeda, a long-acting oxyntomodulin peptide – a drug compound using this technology that is being developed for the treatment of obesity – and PROLOR has now exercised its option to license the technology. The definitive license agreement has an expanded scope and includes all therapeutic indications, with the exception of hemophilia and insulins.
The new licensed technology has the potential to enhance PROLOR’s capabilities in developing long-acting peptide and small molecule drugs, serving as a complementary technology to PROLOR’s core CTP platform for extending the duration of therapeutic proteins and peptides, and potentially enabling PROLOR to develop long-acting therapeutic drugs of many kinds.
“This license from the prestigious Weizmann Institute of Science represents an exciting opportunity for PROLOR,” said Dr. Phillip Frost, Chairman of PROLOR. “It complements our core platform and expands our pipeline of competitive long-acting therapeutic drug candidates to include new, important clinical indications.”
Oxyntomodulin is a naturally occurring peptide hormone released by the digestive system following food ingestion that acts as a natural satiety signal to reduce food intake and increase energy expenditure. Previous third party studies in humans have demonstrated the potential of oxyntomodulin to reduce appetite and food intake, leading to significant weight loss without side effects. However, oxyntomodulin must be administered by subcutaneous injection and its short half-life may require frequent dosing. PROLOR’s long-acting oxyntomodulin, which is expected to have a more favorable dosing profile, is currently in preclinical development.
Yeda Research and Development Company Ltd. is the technology transfer and commercial arm of the Weizmann Institute of Science. The Weizmann Institute of Science is a world-renowned center of multidisciplinary research and higher learning based in Rehovot, Israel.
ABOUT PROLOR BIOTECH PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of
dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in Phase II clinical development, and factor VII, factor IX, interferon beta and erythropoietin, which are in preclinical development, as well as an anti-obesity peptide and agents for atherosclerosis and rheumatoid arthritis. For more information, visit www.prolor-biotech.com
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR’s long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR’s business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel’s Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR’s filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
PROLOR CONTACT: MEDIA CONTACT:
Shai Novik, President Barbara Lindheim
PROLOR Biotech, Inc. GendeLLindheim BioCom Partners
Tel: [phone] [phone]
Email: [e-mail].

[califax]

Judge’s decision has broad implications for generic versions of biologic drugs and companies who make them

Written by Patrick Crutcher
Wednesday, 25 August 2010 02:23

http://biomedreports.com/articles/most-popular/51615-judges-decision-has-broad-implications-for-biosimilars-companies-.html

A judge’s decision will have vast implications for some of the biosimilar companies in the healthcare sector.

Shareholders of Sanofi-Aventis (NASDAQ:SNY) and Momenta Pharmaceuticals (NASDAQ:MNTA) are anxiously awaiting a judge’s decision on whether to block the sale of a generic version of SNY’s blockbuster Lovenox. This comes after MNTA gained FDA approval for their generic version of Lovenox, a biologic-like blood thinner, and SNY later sought a temporary restraining order and preliminary injunction directing the FDA to suspend and withdraw its approval of MNTA’s generic version. Many were caught off guard, since this was the first approval of a generic version of a complex-drug like Lovenox in over 10 years.

To be specific, biosimilars or follow-on biologics are essentially generic versions of biologic drugs. Essentially, biologics are genetically engineered proteins derived from genes(human, animal, micro-organism) and involve some type of biological process to produce the medicinal product. As you can tell, these are incredibly complex-drug process, which are vastly different from creating copycat versions of typical drugs that usually only involve chemical processes. This is why the significance of MNTA’s approval is shaking the market and causing SNY to seek legal action.

The implications for MNTA and other biosimilar companies are far reaching and complex. If the judge throws out the case, MNTA and their partner Sandoz of Novartis (NASDA:NVS) will be cleared to compete with Lovenox, which had worldwide sales of $4 billion and 60% of that was in the US. They are planning on selling their generic version at roughly 30-35% less than Lovenox’s price. MNTA also has a great pipeline full of other potential blockbuster biosimilars, so they want all the cash they can get to pay their development. MNTA has another biosimilar awaiting FDA approval – M356(partnered with Sandoz), which is a biosimilar of TEVA’s $2.8 billion blockbuster Copaxone. Additionally, they have M118, a novel anti-coagulant for patients with acute coronary syndrome and M402, a novel preclinical anti-cancer compound with anti-metastatic properties and low anticoagulant activity.

This will also set precedence for other biosimilar type companies seeking to compete with other blockbuster drugs that are close to coming off patent protection, in particular, Teva’s (NASDAQ:TEVA) $2.8 billion blockbuster Copaxone and Amgen’s Procrit/Epogen and Enbrel which had US sales of over $6.5 billion. These will certainly be main targets in the follow-on biologics war that is coming and other big pharmas have taken notice. In late 2009, Insmed Inc.(NASDAQ:INSM) sold off their follow-on biologics unit to Merck (NASDAQ:MRK) for $123M. A positive result from the case could also lead to more mergers and acquisitions in this biotech area, since some of the larger pharmas have expressed great interest in this area. Pfizer has expressed great interest in this area and Teva Pharmaceutical (Nasdaq: TEVA), Novartis (NYSE: NVS), and Hospira (NYSE: HSP) already have approvals in the European Union for biogenerics. Companies like Protalix BioTherapeutics Inc. (AMEX: PLX), Peregrine Pharmaceuticals, Inc. (NASDAQ: PPHM), PROLOR Biotech Inc. (AMEX: PBTH), Intellipharmaceutics (NasdaqCM: IPCI), and even iBio, Inc. (OTC: IBPM.OB) would certainly benefit from a positive opinion on the case. These companies pipelines and prospects would certainly warrant further attention from large pharmas.

A positive ruling for SNY would certainly send MNTA back down to the $10 range, since their future would be tied up in the courts. It would also cast into doubt a clear approval pathway for biosimilars, since the Pathway for Biosimilars Act of 2009 and Patient Protection and Affordable Care Act of 2010 would certainly come into question under U.S. Judge Emmet Sullivan’s ruling, if SNY were favored in the case.

The judge claims that he plans on delivering a decision soon. I imagine most investors in MNTA or SNY are wound tight, since it is not clear which way he is leaning on the issue. MNTA and SNY also have to worry about TEVA being close on their generic version of Lovenox, which I am sure will be stalled until a decision is made. One thing is for sure, either big pharma wins or biosimilars are on the way.

[califax]

Pipeline Covering An Existing $25 billion Market

http://www.prolor-biotech.com/?CategoryID=0&ArticleID=76

Human growth hormone ($3 billion market, entering Phase II) that could potentially be injected twice per month instead of daily injections. Interferon beta for multiple sclerosis ($4.5 billion market) that may have dramatically lower side effects. Our CTP-enhanced therapeutic proteins pipeline has the potential to dominate a $25 billion market. Our products are expected have significant competitive advantage over current therapies via reduced injection frequency and lower side effects. Our products will:

* Dramatically reduce the number of interventions required to achieve the same therapeutic effect from the same dosage; e.g. reduce the number of injections needed from a daily schedule to weekly.

* Gain extended patent protection as proprietary new formulations of existing therapies;

* Achieve faster commercialization with lower risks and costs than those typically associated with a new therapeutic protein; and

* Be manufactured using industry standard biotechnology based protein production processes.



Corporate Fact Sheet

Please open the PROLOR Biotech Corporate Fact Sheet by clicking
http://www.prolor-biotech.com/_Uploads/dbsAttachedFiles/PROLORCorporateFactSheet.pdf

[califax]

...up it goes! (Chart: AMEX-Listing)

[califax]

CHART (Amex:PBTH)

[califax]

PROLOR Biotech Receives FDA Clearance for a Phase II Trial of Its Long-Acting Human Growth Hormone in the U.S.

PROLOR Biotech Inc
PBTH | 8/24/2010 7:30:00 AM
NES-ZIONA, Israel, Aug 24, 2010 /PRNewswire via COMTEX News Network/ --

http://www.stockhouse.com/News/USReleasesDetail.aspx?n=7850136

PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial in the U.S. of its longer-acting version of human growth hormone, hGH-CTP. The regulatory clearance followed PROLOR's submission of an Investigational New Drug (IND) application for hGH-CTP that included preclinical and Phase I clinical data, as well as plans for additional animal studies that the company intends to complete prior to initiation of Phase III trials. The hGH-CTP Phase II clinical program is currently ongoing in various clinical centers in Europe.

"The FDA regulatory clearance for conducting a Phase II trial of hGH-CTP in the U.S. is an important milestone for PROLOR," said Dr. Abraham Havron, CEO of PROLOR. "This Phase II trial, which is underway at centers in a number of European countries, is an integral part of a comprehensive and coordinated clinical development program that has been carefully designed to generate the data that we anticipate will be necessary to obtain future marketing authorization in the U.S. and Europe, as well as in other localities. We currently do not plan to include sites in the U.S. in this Phase II trial, but the FDA clearance helps ensure that we will be fully in sync with regulatory requirements in key territories, including the U.S., allowing us to utilize the hGH-CTP European Phase II program as the basis for our anticipated submission of applications to conduct Phase III trials in both the U.S. and Europe."

PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. The hGH-CTP Phase II clinical program follows a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.

The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides. For more information on PROLOR, visit www.prolor-biotech.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

PROLOR CONTACT: MEDIA CONTACT: Shai Novik, President Barbara Lindheim PROLOR Biotech, Inc. GendeLLindheim BioCom Partners Tel: [phone] [phone] Email: [e-mail]

SOURCE PROLOR Biotech, Inc.
Copyright (C) 2010 PR Newswire. All rights reserved

[califax]

Study Published in the Journal Endocrinology Further Confirms Therapeutic Potential of PROLOR's Long-Acting Human Growth Hormone

PROLOR Biotech, Inc.
Monday August 2, 2010, 7:30 am EDT
http://finance.yahoo.com/news/Study-Published-in-the-prnews-3583197343.html?x=0&.v=1

NES-ZIONA, Israel, Aug. 2 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today reported publication of a preclinical study in the current on-line edition of the journal Endocrinology showing that human growth hormone (hGH) linked to PROLOR's carboxyl terminal peptide (CTP) technology has significantly increased half-life and bioactivity compared to commercially available hGH. The publication, which is authored by PROLOR researchers, will also be included in the September print edition of Endocrinology.

PROLOR is developing hGH-CTP to provide growth hormone deficient adults and children with growth hormone therapy that requires only once-weekly or bi-monthly injections, rather than the multiple injections per week required by current hGH regimens. PROLOR recently initiated a Phase II clinical trial of hGH-CTP, following a successful Phase I trial that suggested that hGH-CTP, in addition to meeting all safety and tolerability endpoints, could potentially be effective when injected just twice per month.

"The publication of this study in Endocrinology, considered to be one of the most authoritative biomedical research journals in the world, further validates the growing body of clinical and preclinical data supporting the ability of CTP technology to significantly extend the half-life and duration of action of therapeutic proteins," said Dr. Fuad Fares, lead author of the study and Chief Scientific Officer of PROLOR. "Therapeutic proteins are increasingly important treatments for a variety of diseases, and we believe the demonstrated ability of CTP technology to reduce the frequency of required injections could provide important benefits to the many patients who depend on these drugs. We look forward to completing the ongoing Phase II trial of hGH-CTP and anticipate initiating Phase III studies during 2011."

The publication is currently available on-line at: http://endo.endojournals.org/cgi/content/abstract/en.2009-1431v1. It will be published in the September print edition of Endocrinology as "Designing a Long-Acting Human Growth Hormone (hGH) by Fusing the Carboxyl-Terminal Peptide of Human Chorionic Gonadotropin Subunit to the Coding Sequence of hGH," Fuad Fares, Rachel Guy, Ahuva Bar-Ilan, Yana Felikman, and Eyal Fima, Endocrinology, September 2010.151(9).

ABOUT PROLOR'S hGH-CTP PHASE II CLINICAL TRIAL

The hGH-CTP Phase II trial is a randomized, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected either weekly or twice-monthly in patients with growth hormone deficiency who currently receive daily injections of growth hormone. The trial is being conducted at up to 14 sites in six countries.

ABOUT THE JOURNAL ENDOCRINOLOGY

Endocrinology has defined the science of endocrinology for most of the twentieth century. One of the most authoritative biomedical research journals in the world, it publishes 6,000 pages annually of the highest quality original work ranging from subcellular mechanisms to whole animal physiology. Topics include bone and mineral; growth factors; reproductive/steroids; neuroendocrinology/signal transduction; thyroid; and physiology. The low manuscript acceptance rate of 30% reflects the degree to which it is committed to the highest scientific standard.

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting, biobetter, proprietary versions of already-approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins, and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, which are in preclinical development, as well as GLP-1 and other therapeutic peptides. For more information on PROLOR, visit www.prolor-biotech.com.

Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.

PROLOR CONTACT:


MEDIA CONTACT:


Shai Novik, President


Barbara Lindheim


PROLOR Biotech, Inc.


GendeLLindheim BioCom Partners


Tel: [phone]


[phone]


Email: [e-mail]

[gym gravity]

PBTH looking great... I am down to 400 shares only because I bought so cheap and no matter where I think the pps is going I have to follow my rules.

I may hold 200 shares to 200 dollars and all the way up I will deal with the regret of selling too early, but more likely, I will pat myself on the back for my prudent decisions, which may include buying back in and selling out again.

[gym gravity]

Looks like PBTH is holding up quite well on the big boards.

Should be added to some index funds soon (and bought up in anticipation).

[B7$4]

"PBTH NEWS" PROLOR Biotech Reports New Preclinical Data Supporting the Enhanced Biological Activity Potential of Its Biobetter Pipeline

http://www.sunherald.com/2010/05/03/2147963/prolor-biotech-reports-new-preclinical.html

NES-ZIONA, Israel, May 3 -- /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today reported new preclinical data on the company's pipeline of drug candidates designed to reduce the dosing frequency of therapeutic proteins and peptides. The data will be discussed by PROLOR's management at the 2010 BIO International Convention in Chicago, as well as at the upcoming Rodman & Renshaw 6th Annual Global Healthcare Conference in London and the Jefferies 2010 Global Life Sciences Conference in New York City.

The data includes an update on PROLOR's preclinical development program for its CTP-enhanced version of interferon beta (IFN-Beta), a widely used drug for the treatment of multiple sclerosis (MS). In January 2010, the company reported positive results from a study in primates comparing intravenous injections of commercial IFN-Beta with PROLOR's CTP-enhanced version of IFN-Beta. PROLOR's new data includes the results of experiments comparing IFN-Beta-CTP with commercially available IFN-Beta administered by subcutaneous injection.

The preclinical data shows that the AUC (overall drug exposure) of PROLOR's CTP-modified IFN-Beta administered subcutaneously was more than 200 times greater than an equivalent dose of commercial IFN-Beta, expanding on the results in the January study, which showed that CTP-modified IFN-Beta administered intravenously had 55 times greater overall drug exposure compared to commercial IFN-Beta. In both studies, CTP-modified IFN-Beta also demonstrated strong biological potency as measured by several well-validated biomarkers. The results further validate the potential of IFN-Beta-CTP to significantly reduce the current dose level and dosing frequency of interferon beta for the treatment of MS, potentially also reducing the associated side effects.

PROLOR is also presenting preclinical data on its programs for CTP-enhanced Factor Vll and Factor lX, potential drugs for the treatment of blood clotting disorders. In these studies, the durability of the CTP-enhanced compounds was increased approximately three to six-fold compared to commercially available Factor VII and Factor IX. In addition, the company is presenting initial data on its novel anti-obesity peptide showing that the durability of its biobetter version is 100 times greater than the durability of the naturally-occurring anti-obesity peptide.

[B7$4]

"PBTH News" PROLOR Biotech Awarded Second Israeli Government Grant to Support Development of its Longer-Acting Interferon Beta

http://www.prnewswire.com/news-releases/prolor-biotech-awarded-second-israeli-government-grant-to-support-development-of-its-longer-acting-interferon-beta-89676117.html

-- Interferon-Beta-CTP Development Program Has Been Approved For Second Year Funding Through a Special Grant from the Israeli Office of the Chief Scientist --

NES-ZIONA, Israel, April 1 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that the Israeli Office of the Chief Scientist ("OCS") has approved a 2010 continuation of its grant to PROLOR's Israeli-based R&D subsidiary for the company's development program for interferon-beta-1a-CTP (IFN-Beta-CTP), its longer-acting version of interferon-beta-1a (IFN-Beta). IFN-Beta, which is indicated for the treatment of multiple sclerosis (MS), is currently marketed by Merck Serono as Rebif® and by Biogen Idec as Avonex®, with combined 2009 annual sales estimated at more than $4.4 billion worldwide.

PROLOR recently reported positive results from a study in primates comparing PROLOR's CTP-modified IFN-Beta with commercially available IFN-Beta. The study showed that in primates, PROLOR's CTP-modified IFN-Beta had 13 times greater durability (half-life) and 55 times greater overall drug exposure (AUC) compared to commercially available IFN-Beta. IFN-Beta-CTP also demonstrated strong biological potency as measured by several well-validated biomarkers.

Based on the results of the comparative study, the OCS approved a special continuation grant to support PROLOR's IFN-Beta-CTP program for 2010. The grant is expected to provide cash reimbursements for approximately 35% of the estimated $1.5 million in expenses expected to be paid for IFN-Beta-CTP product development during 2010.

"This generous continuation grant from the OCS is an important non-dilutive cash resource for PROLOR's IFN-Beta-CTP development program, and we believe that it represents another validation of the potential of our CTP technology," said Abraham Havron, Ph.D., Chief Executive Officer of PROLOR. "Going forward, we also hope to obtain an average of 35% cash reimbursements from the OCS for our IFN-Beta-CTP development expenses in 2011 and 2012. This visionary program is particularly attractive for PROLOR because the grants are repaid only upon the generation of commercial revenue from IFN-Beta-CTP or our other CTP-based products. We are grateful for this valuable source of non-dilutive capital."

Under the terms of the grant, PROLOR is required to repay the OCS the sum of the grant plus accrued interest through a series of payments that would begin only when the IFN-Beta-CTP product or other products that PROLOR develops with its CTP technology begin to generate commercial revenues.

[gym gravity]

edited the ibox now that Prolor is now no longer a .OB

noticed that the website is no longer "modigene" so I changed the link to Prolor's website.

Last Trade: 4.25
Trade Time: 10:56am ET
Change: 0.00 (0.00%)
Prev Close: N/A
Open: 4.05
Bid: 4.25 x 2400
Ask: 4.27 x 100
1y Target Est: N/A
Day's Range: 3.97 - 4.25

[gym gravity]

everything going according to plan.

[B7$4]

"PBTH News" PROLOR Biotech Announces NYSE AMEX Listing Trading on NYSE AMEX Begins Monday, March 29, 2010 under Symbol "PBTH" -
March 25, 2010: 08:00 AM ET

http://money.cnn.com/news/newsfeeds/articles/prnewswire/NY76304.htm

NES-ZIONA, Israel, March 25 /PRNewswire-FirstCall/ -- PROLOR Biotech, Inc., (OTC Bulletin Board: PBTH), a company developing next generation biobetter therapeutic proteins, today announced that it has been authorized to list its shares of common stock on the NYSE AMEX stock exchange. The company anticipates that its common stock will begin trading on the NYSE AMEX on Monday, March 29, 2010, under the trading symbol "PBTH." Until that time, PROLOR's common stock will continue to trade on the OTC Bulletin Board under the trading symbol "PBTH."

"We are pleased to be moving the listing of our common stock from the OTCBB to the NYSE AMEX," said Shai Novik, President of PROLOR. "This is an important milestone that we anticipate will raise PROLOR's profile in the global investor community and permit a larger number of institutional funds to consider adding PROLOR to their investable universe. Listing on the NYSE AMEX marks an important step in our ongoing efforts to improve the liquidity of our common stock while we continue to execute our growth strategy."

"We welcome PROLOR Biotech to the NYSE Euronext family of listed companies and to NYSE AMEX," said Scott Cutler, NYSE Euronext Executive Vice President and Head of Listings, Americas. "PROLOR Biotech and its stockholders will benefit from our superior market quality and technology, a broad array of issuer and investor services, and a global brand association. We look forward to building a strong and lasting partnership with the company and its stockholders."

Earlier this year, PROLOR reported results from a Phase I clinical study of its biobetter form of human growth hormone (hGH) that demonstrated its potential to reduce the required dosing frequency from one injection per day as required for currently available hGH to as few as two injections per month. Last week, PROLOR announced that it had closed a $24.4 million private placement of its common stock.

[gym gravity]

re-set the uplist clock now that the bid is over $3 for pbth.

50sma was rock solid support.

[gym gravity]

2.60 seems like support now, looking good this morning.

[gym gravity]

PBTH getting on top of a good support level today...2.70

what a shake out the other day.

may have busted the $3 bid rule for x number of days for uplisting to this exchange or that but I am not sweating.

you see it in the chart, the people that sold on friday were traders who bought "uplist fervor"... they sold (or were tricked to sell) because of the one close below $3.

http://stockcharts.com/h-sc/ui?s=PBTH&p=D&yr=3&mn=0&dy=0&id=p35450560666

[gym gravity]

cool thanks, expected a bunch of targets to be refined with the data released early. conference next week too.

[surf1944]

PROLOR Biotech PBTH Ladenburg Thalmann Buy $5 to $9

http://www.briefing.com/Investor/Public/Calendars/UpgradesDowngrades.htm

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new chart, delay updating link:

here's another chart that shows that $2.70 is strong support and that not a lot of people are selling right here.

$3 should be support if they say anything about uplisting and going into a conference with new, big news.

(notice the big black horizontal volume by price bars and the thin slivers of red)



http://stockcharts.com/h-sc/ui?s=PBTH&p=D&yr=3&mn=0&dy=0&id=p35450560666

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PROLOR BIOTECH REPORTS POSITIVE TOP-LINE RESULTS FROM PHASE I STUDY
OF ITS LONGER-ACTING VERSION OF HUMAN GROWTH HORMONE
––Data Show PROLOR’s Biobetter Form of hGH has Potential to Reduce Required
Dosing Frequency from One Injection Per Day to Two Injections Per Month––
––Phase I Safety and Tolerability Endpoints Met––
Nes-Ziona, Israel – February 2, 2010 – PROLOR Biotech, Inc., (OTCBB: PBTH) today
reported positive top-line results from a Phase I study of its longer-acting version of human
growth hormone (hGH). The study was designed to measure the potential durability (halflife),
overall drug exposure (AUC) and biological efficacy, as well as the safety and
tolerability of PROLOR’s longer-acting CTP-modified human growth hormone (hGH-CTP).
The Phase I study enrolled 24 healthy adults who were randomized to receive one of three
doses of hGH-CTP (4mg, 7mg, or 21mg) or placebo. The study results showed that safety
and tolerability endpoints were met at all doses in all participants. The potential clinical
efficacy of hGH-CTP was assessed by measuring the extent to which hGH-CTP induced
insulin-like growth factor-1 (IGF-1) in subjects. This biomarker is the clinically accepted
primary indicator of hGH biological activity and is used by endocrinologists to optimize
dosing for hGH-deficient adults. Based on this measure, the study results suggest that the
daily injections required by patients using conventional hGH could potentially be replaced
with just two monthly injections of hGH-CTP.
“We believe that the results from this first human clinical trial of a PROLOR CTP-modified
drug are very encouraging and exemplify the promise of biobetter therapeutics,” said Dr.
Avri Havron, CEO of PROLOR Biotech. “Our hGH-CTP appears to be a safe and highly
potent version of commercially available human growth hormone. Replacing the daily
injections required by current hGH users with just two injections per month could
dramatically improve the quality of life for patients receiving growth hormone therapy.
Based on these Phase I results, we anticipate moving forward rapidly with the planning and
execution of a Phase II study of hGH-CTP.”
ABOUT hGH-CTP
hGH-CTP is PROLOR’s proprietary biobetter version of human growth hormone. hGH is
used for the long-term treatment of children and adults with growth hormone deficiency due
to inadequate secretion of endogenous growth hormone. It is also sometimes used to
counter involuntary weight loss and certain physical manifestations of aging. Currently
available forms of hGH must be injected daily. In contrast, hGH-CTP is expected to require
only bi-monthly or weekly injections. Current global sales of human growth hormone
products are estimated at about $3 billion annually.

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nice old PBTH chart in previous post.

new chart:

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from "wiito" on YMB. Keep in mind the HGH news is out and we got a good $1 out of that news...that means add another $6 to the pps if the data looks good in february.:

Positive Results Phase 1: $6-8(280MM MC)end of Feb

Positive Results Interferon pre clinical: should add 1 more dolar, hence $7-9 ($300MM MC)

Positive Results Phase 2: $12-15($600MM MC) year end.

thats assuming no takeover bids. In case of takeover, high watermark should be $20. Positive results for human growth and interferon should validate complete CTP pipeline.

Fully developed pipeline should be worth more than $3 billion. A conservative NPV analysis yields a ballpark figure of $1.3 billion. AIMHO

Rating : (1 Rating)Rate it: wiiito

Male

[gym gravity]

Nice long article thanks to Joseph Krueger.

PROLOR Biotech (PBTH): A Solution to Big Pharma’s Problems 0 comments
Jan 26, 2010 04:43 PM | about stocks: MRK, AMGN
Font Size: PrintEmail TweetThis In my last article I wrote about how 2010 is shaping to be an amazing year for biotech, probably to a degree not seen since the biotech boom of 1999.

http://seekingalpha.com/article/182930-the-future-of-biotech-party-like-it-s-1999

I described the pressures that are mounting on big pharma that will drive an acquisition and partnership spree which would benefit biotech:
-Blockbuster drugs are going generic-A more nationalized healthcare system may not pay for expensive biologics-Big pharma needs to come up with new drugs and applications that will fit under the intentions of the pending health-care bill.

The most obvious solution for this problem is for big pharma to acquire new drugs that match the indication and purpose of their current revenue generating drugs that are threatened with patent expiration. These types of drugs are often called “biosimilars”, and these drugs have reduced development risk, as their biology and mechanisms are known, and a company can maintain its market share of an expiring drug by “replacing” the current marketed drug with the “new version”. One significant advantage to the biosimilar development approach is the expedited clinical development process leading to approval. Biosimilar replacements for currently marketed biologics can now gain approval with an Abbreviated New Drug Application (“ANDA”) under the new Biosimilars Amendment (Hatch-Enzi-Hagan Amendment) in the “Affordable Health Choices Act” passed in July 2009. In order to gain approval, the company must show must show that the biosimilar has the “same active moiety,” and a demonstration of pharmaceutical equivalence and bioequivalence to the reference listed drug. The biosimilar must be highly similar to reference notwithstanding minor differences in clinically inactive ingredients; no clinically meaningful differences in safety, purity, potency compared to the reference. Thus there is a faster pathway to market, with significantly reduced regulatory burden. In addition, these biosimilars fall under new patent protection, effectively extending the exclusivity of the old drug it is replacing.

I suggested that the investor best take advantage of this situation by looking for companies which are ripe for a buyout or lucrative partnership. More specifically, look for small biotech companies that have technology or biosimilar drugs which will help big pharmaceutical companies overcome the current stresses. PROLOR Biotech, Inc. (PBTH.OB), formally known as MODIGENE, is exactly such a company. PROLOR is a biopharmaceutical company developing such biosimilars, which will enable big pharma to re-market new, more effective versions of their existing drugs and extend the life of their patents by modifying their therapeutic proteins. PROLOR is applying its patented “CTP technology” to develop longer-acting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. PROLOR Biotech`s technology is the use of a naturally occurring amino acid sequence called CTP to slow the removal of therapeutic proteins from the body without increasing toxicity or altering the overall biological activity. By adding this CTP sequence to different therapeutic proteins, the life span of the CTP-modified therapeutic proteins are dramatically increased. The CTP technology is applicable to virtually all proteins and PROLOR is currently developing long-acting versions of human growth hormone, which is in clinical development, and interferon beta, factor VII, factor IX and erythropoietin, GLP-1, and other therapeutic peptides.

As natural substances, the body has normal routes of degradation and elimination for biologicals. As such, they have to be administered repeatedly through injection to maintain adequate levels in the body. One simple way to fix this problem (in concept) is to modify the protein to last longer in the body; providing longer and better efficacy, and less frequent dosing. This is usually attempted by increasing the size and structure of the therapeutic protein so that degrading enzymes cannot access the protein. This is accomplished by attaching large polymeric chains to the protein (PEGylation), carbohydrate structures to the therapeutic protein (glycosylation), or by attaching other large, non-active proteins that have longer life spans compared to the target therapeutic protein. However these modifications introduce their own problems. The modified protein may be less potent or may no longer be functional. This process may require making mutations in the protein, which can often generate unexpected adverse reactions, resulting in potentially toxic effects. The body may also recognize the altered protein as a foreign substance that it should fight off, and develop an immune response against the molecule, causing side effects and rendering it useless.

Thus, the creation of a successful, non-toxic and non-immunogenic long-lasting therapeutic protein is a very "tricky" process.As proof of the size of these hurdles to overcome, these approaches have only been successful with three therapeutic proteins on the market. Schering-Plough (now Bayer) and Roche independently developed a PEGylated form of interferon alpha (INF-alpha) used to treat hepatitis C, called PEGIntron and Pegasys respectively. Amgen developed Aranesp, a glycosolated eurythopoetin; and Neulasta, a glycosolated G-CSF. Collectively, these three products have revenues of more than $8 billion a year, demonstrating the need and value of developing improved therapeutic proteins.

PROLOR’s CTP can readily be attached to a wide array of existing therapeutic proteins, stabilizing the therapeutic protein in the bloodstream and greatly extending its life span without additional toxicity or loss of desired biological activity as found using other methodologies. CTP-modified proteins can be manufactured using established recombinant DNA techniques in widely used in the manufacture of biologicals. Proteins utilizing CTP have been shown to have up to 10 times longer biological half life time as compared to the commercial non fused protein, resulting in 55 times longer exposure!

PROLOR licenses the intellectual property necessary to perform this work. Their license is exclusive, with the right to sub-license, for all therapeutic proteins and peptides. Their license specifically excludes four endocrine proteins - LH, FSH, TSH and hCG, which were previously licensed exclusively to Schering-Plough. However, even with these few exclusions, successful application for this technology is potentially an $80 BILLION market! The successful application of CTP to any of the following already marketed drugs would potentially yield the same revenues as their currently marketed biologicals. A number of inflammatory diseases, such as rheumatoid arthritis, are treated with biological drugs which are administered by injection. Among the currently approved treatments, Enbrel (etanercept), Rituxan/Mab Thera (rituximab) and Remicade (infliximab) have been on the market for more than a decade and will lose patent protection in the next few years. The high revenue from these drugs is likely to make companies developing biosimilars strong candidates for partnerships or buyouts. For large pharmaceutical companies with the capability to produce biologicals, and the money to invest in their development, there is enormous potential in this high-value market:

$16 Billion: Anti- TNF Antibodies (Enbrel, Remicade, Humira, Cimzia)
$16 Billion: Anti- Cancer Antibodies (Rituxan/ MabThera, Herceptin, Avastin, Erbitux, Vectibix)
$12 Billion: Insulin and Insulin Analogs (Humalog, Humulin, Lantus, Levemir, Novorapid, Actrapid, Novolin)
$11 Billion: Erythropoietins (Aranesp, Procrit Eprex, Epogen, Neo-
Recormon, ESPO, Dynepo, Binocrit)
$8 Billion: Interferons (Avonex, Rebif, Betaferon / Betaseron, Pegasys, Peg- Intron, Intron A)
$6 Billion: G- CSF (Neulasta, Neupogen, Neutrogin)
$6 Billion: Coagulation Factors (Novoseven, Kogenate, Helixate, Refacto, Advate, Recombinate, Benefix)
$3 Billion: Enzyme Replacement (Cerezyme, Fabrazyme, Aldurazyme,
Myozyme, Replagal, Naglazyme, Elaprase)
$3 Billion: Human Growth Hormone Genotropin, Norditropin, Humatrope, Nutropin, Saizen, Serostim, Omnitrope)
$2 Billion: Ophthalmic Antibodies (Lucentis)
$1 Billion: Antiviral antibodies (Synagis)

Total: $80 Billion (figures based on 2008 sales)

PROLOR’s CTP modified proteins fit under the new ANDA umbrella, allowing a quick time-to-market and instant revenue generation. The value of the CTP technology and speed of regulatory approval has already been proven by Merck& Co: Merck & Co has used the CTP technology to extend the life of Follicle-Stimulating Hormone (FSH) for fertility treatments. Merk's FSH-CTP requires only one injection, compared to the seven injections required for the regular FSH treatment. After as successful phase III human clinical trial, in November 2009 the European Medicines Agency gave Merck & Co. a positive opinion for marketing approval in Europe for FSH-CTP, now branded as ELONVA®. Merck & Co.'s success indicates that the addition of CTP to existing therapeutic proteins is commercially viable.

As testament to the speed at which the CTP modified proteins can move through clinical trials, in September 2009 PROLOR announced that they would be initiating their phase I trial of CTP modified hGH (human growth hormone). In January 2010, they announced that they will present the complete data on February 8-9, 2010. That is only 4 months for a completed trial! To date Prolor has been issued by the U.S. Patent Office two new proprietary patents covering our long-acting hGH and EPO drug candidates. PROLOR has a deep pipeline of CTP modified biologicals, which are strategically chosen to meet the current unmet needs for them:

MOD-4023: hGH-CTP – $3 billion current market, no available long-lasting therapeutics
MOD-9023: IFN-ß-CTP – $5 billion current market, no available long-lasting therapeutics
MOD-5023: Factor VIIa-CTP – $1 billion current market, no available long-lasting therapeutics
MOD-7023: EPO-CTP - $11 billion current market, available long-lasting therapeutics
MOD-1001: GLP-1-CTP – $1 billion estimated potential market, no available long-lasting therapeutics
MOD-1002: OBES-CTP – $5 billion estimated potential market, no available long-lasting therapeutics

In 2010, the efforts of PROLOR are paying off and it is attracting a lot of well deserved attention for its progress:
On January 25th, 2010, PROLOR Biotech reported positive results from a comparative study of its longer-acting version of the multiple sclerosis drug Interferon Beta (IFN-beta-CTO) in primates . The study results showed that PROLOR's CTP-modified IFN-beta showed 13 times prolonged durability (half-life), and 55 times prolonged overall exposure and enhanced biological potency. The expanded biological potency seen in this new study is consistent with the results of a previous study in mice conducted by PROLOR, which compared the anti-tumor activity of IFN-beta-CTP to commercially available IFN-beta in a model of human cancer. In that study, IFN- beta-CTP showed 100% inhibition of human melanoma tumors implanted in nude mice after eight days and 87.5% inhibition after 10 days, versus 50% inhibition with commercially available IFN-beta after eight days and just 12.5% inhibition after 10 days. Development of this drug may allow PROLOR to tap the $5 Billion market for IFN-beta in MS and its enhanced efficacy may allow it to enter the cancer therapy market as well. On January 19, 2010, PROLOR announced that final data from a randomized, dose-escalating Phase I clinical study of its longer-acting version of human growth hormone (hGH-CTP) will be featured in an oral presentation by PROLOR management at the 12th Annual BIO CEO & Investor Conference to be held at the Waldorf-Astoria Hotel in New York City on February 8-9, 2010. The presentation which will also include an update on progress in other PROLOR programs. I expect this presentation to open up investors eyes to PROLOR, and see the close-range $25 BILLION market its pipeline biosimilars can tap. With approval of its furthest along biosimilar, CTP IFN-beta, it could easily conquer most of that $5 BILLION market share through partnership with any one of the major companies who has this type of product on market. This alone would make the value of PROLOR at least $1 billion, or 10 times its current market cap. This is without considering any of its other pipeline products.

However, I feel the PROLOR will not get the opportunity to ever develop such a partnership, because it is an obvious target for a buyout. Given that its pipeline can potentially replace much of the $18 BILLION biologics market, and solve the problem of these drugs coming off patent, the value of its pipeline (if successful) is at least $5 billion. With a clean balance sheet, and a fast moving pipeline, PROLOR is exactly the kind of company that will be snatched up at a very high premium to its current market value very soon.

Disclosure: I have a long position in PBTH
Themes: biosimilars, biotech, pharmaceuticals, biologicals Stocks: MRK, AMGN

http://seekingalpha.com/instablog/492120-joseph-krueger/45652-prolor-biotech-pbth-a-solution-to-big-pharmas-problems

[madstockscientist]

I am here with ya....we will hear more about this one soon.

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PROLOR news:

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=45845818

http://finance.yahoo.com/news/PROLOR-Biotech-Reports-prnews-1410854622.html?x=0&.v=1

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Prolor big holder has options to buy more:

From sec filing:

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2009


(Unaudited)


NOTE 1:- GENERAL

a. PROLOR Biotech, Inc. (the “Company”) was formed on August 22, 2003 under the laws of the state of Nevada. The Company is engaged in the development of therapeutic proteins with extended half-lifes, through its subsidiaries, Modigene Inc., a Delaware based subsidiary and ModigeneTech Ltd., an Israeli based subsidiary.
On June 12, 2009 the company changed its name from Modigene Inc. to PROLOR Biotech, Inc.

b. The Company is devoting substantially all of its efforts toward conducting research and development activities. The Company’s activities also include raising capital, recruiting personnel and building infrastructure. In the course of such activities, the Company has sustained operating losses and expects such losses to continue for the foreseeable future. The Company has not generated any revenues or product sales and has not achieved profitable operations or positive cash flow from operations. The Company’s deficit accumulated during the development stage aggregated $24,380,770 through September 30, 2009. There is no assurance that profitable operations, if ever achieved, could be sustained on a continuing basis. The Company believes that its current cash sources will enable the continuance of the Company’s activities for at least a year with no need of additional financing.

c. On July 22, 2009, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with certain private investors (the “Investors”), pursuant to which the Investors agreed to purchase an aggregate of up to 5,000,000 shares (the “Shares”) of the Company’s newly-designated 10.0% Series B Cumulative Convertible Preferred Stock, par value $0.00001 per share (“Series B Preferred Stock”), at a purchase price of $2.00 per share. On July 23, 2009 (the “Closing Date”), the Company closed on the issuance of 1,000,000 Shares for aggregate consideration of $1,996,000 ($2,000,000 net of issuance costs of $4,000). Under the Purchase Agreement, the Company may elect, in its sole discretion, to close on the sale and issuance of up to an additional $8 million of Series B Preferred Stock, at a purchase price of $2.00 per share, on any date on or prior to March 25, 2013, subject to providing the Investors thirty days prior written notice of such closing date. The Company must issue a minimum of $2 million of Series B Preferred Stock in any such future closing; however, the Company is not obligated to effect any such future closings.

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Not bad, held up well to the meltdown yesterday. see if the breakout stays broken out.

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old press release on hGH-CTP clinical trial:

http://www.news-medical.net/news/20090921/PROLOR-Biotech-initiates-Phase-I-clinical-trial-of-its-human-growth-hormone-drug-candidate.aspx

PROLOR Biotech initiates Phase I clinical trial of its human growth hormone drug candidate
21. September 2009 08:08

PROLOR Biotech, Inc. (OTC Bulletin Board: PBTH) formerly Modigene Inc., today announced the initiation of a Phase I clinical trial of its long-acting human growth hormone drug candidate hGH-CTP.

hGH-CTP is being developed to provide growth hormone deficient adults and children with the option to replace the multiple injections per week that are currently required with a once-weekly or bi-monthly injection. The initiation of the trial follows a successful safety and immunogenicity study of hGH-CTP in primates and regulatory approvals by the IRB committee of the Tel-Aviv Medical Center and the Israeli Ministry of Health.

The Phase I trial is a randomized, double-blinded, placebo-controlled, single-dose, dose-escalating study to evaluate the safety, tolerability, and pharmacokinetic and pharmacodynamic properties of hGH-CTP in 24 healthy volunteers. It will be conducted at the Early-Phase Clinical Pharmacology Unit located at the Tel-Aviv Medical Center.

"The initiation of a Phase I clinical trial of our long-acting hGH-CTP represents an important milestone for PROLOR," said Dr. Avri Havron, CEO of PROLOR. "We were delighted with the results of our hGH-CTP studies in primates, which showed that hGH-CTP had an excellent half-life and biological activity and was safe at all doses tested without any signs of immunogenicity. We are now eager to obtain data on its bioactivity in humans."

Dr. Havron continued, "This trial is being conducted at the Early-Phase Clinical Pharmacology Unit at the Tel-Aviv Sourasky Medical Center, a top-notch facility that has a successful track record of conducting more than 250 clinical studies for leading global pharmaceutical and biotech companies in a variety of clinical areas. We look forward to completing the Phase I trial so that we can move ahead with the further clinical development of hGH-CTP."

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skyrockets in flight...open airspace above 2.30

Found this on yahoo:

Article came out today in an Israeli paper http://www.globes.co.il/serveen/globes/d...

Roth Capital: Prolor among top 3 biotech firms
"The best time to buy biotech shares is 3-4 months before the completion of a clinical trial."
Oriel Herman29 Dec 09 11:46
Investment house Roth Capital has picked drug delivery firm Prolor Biotech Inc. (Bulletin Board: PBTH) (formerly Modigene) as one of the three most promising biotechnology companies in the US for 2010. This is the third time in the past 18 months that an investment house has predicted a bright future for the company and its share.
Prolor is due to publish the results of the Phase I clinical trial on its human growth hormone. Prolor's share closed at $2 on Wall Street yesterday, giving a market cap of $70 million. The share has been rising steadily, and Roth Capital predicts further rises during 2010: it gives the share a "Buy" recommendation with a target price of $4.

Roth Capital wrote, "We note that Prolor is a tremendously "under the radar" femto-cap stock. Regardless, we believe that its approach to long-acting protein therapeutics is more elegant than existing approaches (which we consider to be "hammer and tongs" approaches, by comparison), and that positive clinical data will bring more attention to this stock, leading to price appreciation."

Roth Capital says, "In our opinion, the following 3 stocks are set to meaningfully outperform the rest of the biotech space in 2010."

The investment house says that empirical data shows that profits can be made simply by purchasing shares of biotech companies in advance of known clinical/regulatory events,and that "good excess returns may be obtained by purchasing shares of companies facing important events 3-4 months prior to the event, and selling before the event."

Prolor uses innovative methods to develop longer-lasting, proprietary versions of already approved therapeutic proteins. The goal is to replace the need for daily injections with less frequent ones. The company is targeting drugs with $80 billion in aggregate global annual sales. The technology is being applied to scores of drugs, hence the company's huge potential.

Prolor chairman Dr. Philip Frost is also the company's largest shareholder. Frost sold Ivax to Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) for $7.4 billion in 2006.

Roth Capital notes in its disclosure that it makes a market in Prolor shares, and that one of its analyst's (or household member) is a shareholder in the company.

Published by Globes [online], Israel business news - www.globes-online.com - on December 29, 2009

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well, it didn't exactly skyrocket but some lucky folks bought the dip on the 24th and now they have almost double. volume coming on strong these days.

http://stockcharts.com/h-sc/ui?s=PBTH&p=D&yr=0&mn=6&dy=0&id=p10704040110